AliveDx receives Health Canada clearance for MosaiQ AiPlex CTDplus

October 2026

AliveDx, the global in vitro diagnostics company that aims to transform patient care, has received Medical Device Licence clearance from Health Canada for its MosaiQ AiPlex® CTDplus multiplex microarray assay, further expanding its automated autoimmune testing portfolio in Canada.

The MosaiQ® solution supports laboratories to increase testing capacity, simplify operations and support confident diagnosis in autoimmune disease

Systemic autoimmune rheumatic diseases, including systemic lupus erythematosus, systemic sclerosis and Sjögren's syndrome, can present with overlapping clinical features, making laboratory testing an important component of the diagnostic pathway.

Designed for use on the MosaiQ® instrument, MosaiQ AiPlex® CTDplus combines 15 markers in a single multiplex microarray, using just 10 µL of sample. By analysing multiple markers simultaneously within a single microarray, MosaiQ® supports a syndromic approach to autoimmune disease diagnostics. This helps laboratories identify complex disease patterns, recognise potential comorbidities and support confident clinical decision-making. In addition, by consolidating multiple tests into one automated workflow, the microarray is designed to allow simultaneous analysis of multiple markers, help laboratories streamline testing, reduce hands-on time and increase testing capacity while providing actionable insights for clinicians.

Expanding the MosaiQ portfolio in Canada

The clearance follows the recent Health Canada Medical Device Licences for the MosaiQ® instrument and MosaiQ AiPlex® VAS assay, strengthening the availability of the MosaiQ autoimmune testing portfolio for laboratories across to deliver diagnostic solutions that can generate clinical and economic value for laboratories and contribute to improved patient care.

"Our goal with MosaiQ is to simplify laboratory workflows while providing fast, comprehensive diagnostic insights that can support clinical decision-making for patients," said Manuel Ó. Méndez, CEO of AliveDx. "The Health Canada clearance for CTDplus represents another important milestone in the expansion of our autoimmune disease assay portfolio and increases the availability of our MosaiQ solution for laboratories and clinicians in Canada."

Learn more about MosaiQ AiPlex® CTDplus